Republicans, EHR vendors want ONC to take over medical app regulation

By: Brian Dolan | Mar 14, 2013        

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Brian Dolan, Editor, MobiHealthNewsThere has been a painfully slow chess game playing out in Washington DC these past two years over the fate of FDA regulation of mobile medical apps.

Last July I wrote about the largely failed attempt by some members of Congress and companies like Aetna, UnitedHealth, and Verizon Communications to insert language into the The Food and Drug Administration Safety and Innovation Act (FDASIA) to slow down the FDA’s issuance of a final guidance document for mobile medical apps. While the legislative attempts to slow the FDA down may not have worked directly, for whatever reason, the FDA has still failed to produce a final document after the draft published almost 20 months ago.

Next week the House of Representatives’ Energy and Commerce Committee, which is led by Rep. Fred Upton (R-MI), is holding a series of hearings about mobile medical app regulation to find out — among other things — why the FDA hasn’t issued final guidance yet. When the committee’s vice chair, Rep. Marsha Blackburn (R-TN), appeared on Fox News this past week to discuss the hearings, she claimed that FDA regulation of mobile medical apps will “drive up the costs of consumers, it will drive up the costs of your cell phone.”

I am very curious to hear the supporting evidence for that claim during the hearings next week.

Notably, the committee chairman, Rep. Upton, was the lead sponsor of the House version of the FDA bill discussed above that included the 18 month moratorium on medical app regulation last year. Instead of an 18 month moratorium, a section within the passed law, (Section 618) mandates that within 18 months (by January 9, 2014) the Secretary of HHS “acting through the” FDA commissioner “and in consultation with” the ONC and FCC chairman has to publish a report that includes a proposed strategy and recommendation for “an appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications, that promotes innovation, protects patient safety, and avoids regulatory duplication.”

It’s worth keeping in mind that the legislation calls for HHS to work through FDA to create this report with help from the others. It’s also worth remembering that the final version of this legislation curiously swept mobile medical apps under the heading of “health information technology” instead of “medical devices”.

While last year’s efforts to disintermediate the FDA on mobile medical app regulation were led by Verizon Communications and others through the Health IT Now Coalition, the most recent efforts to dispel the agency’s purview over mobile medical apps and make apps a part of some kind of new ONC-led certification process, appears to be driven by McKesson and other large health IT companies through the Bipartisan Policy Center (BPC). (For more on why mobile medical app regulation might be worrying EHR vendors, check out our previous coverage on how the FDA’s EHR exempt rule might becoming extinct.)

While last year’s legislation instructs HHS to have the FDA take the lead on creating this risk-based regulatory framework, ONC has already begun to take the reins. This past Friday applications closed for a new ONC FACA (federal advisory committee) specifically focused on the FDASIA Section 618 mandate for a report on a new risk-based regulatory framework for health IT and mobile medical apps. The FDA and FCC helped promote the new ONC group, but it’s clearly being convened by ONC.

To get a better sense of where all this is going and what the future of mobile medical app regulations might look like, be sure to read this letter from McKesson’s head lobbyist and Vice President of Public Affairs Ann Richardson Berkey. It calls on Dr. Farzad Mostashari to ”clearly identify ONC as the agency to exercise appropriate oversight of health IT to support both patient safety and innovation” and to “synchronize [ONC's] patient safety Plan with related meaningful use and other health IT requirements”.

“There are several initiatives underway to address these objectives,” Berkey writes, “including the Meaningful Use program, the Health IT Patient Safety and Surveillance Plan and a provision in FDASIA, which calls for a coordinated plan to address a risk-based regulatory framework for health IT. Since these initiatives may create additional requirements for developers, hospitals and providers, any requisites must be coordinated to avoid redundant or conflicting requirements.”

Berkey goes on to write that the ONC should serve as the “convener” of all these “patient safety” initiatives. She also “urges ONC to include any anticipated near-term patient safety requirements as it finalizes the scope of Meaningful Use Stage 3.”

Last year when the FDASIA legislation was amended to sweep mobile medical app regulation under the heading of “health IT”, it paved the way for ONC to take over from the FDA. Next week’s congressional hearings on mobile health apps will likely steer toward this idea that the FDA should not be regulating apps as medical devices, even though the FDA has been doing so for almost 20 years now. The debate will likely shift to whether ONC should lump mobile medical app regulation into some kind of certification process that is self-policed by the industry — all in the name of “patient safety”, of course.

During her Fox News interview, Rep. Blackburn also let slip that she already had drafted legislation to entirely stop the FDA from regulating mobile medical apps:

“I have draft legislation which is coming out, which would be an express prohibition, prohibiting the FDA from getting into these mobile medical applications as a healthcare medical device,” she said.

If the FDA has any interest in holding onto its regulatory purview, it should issue final guidance for mobile medical apps immediately.

  • http://www.facebook.com/Lupy9 Todd Lupold

    Brian…it’s very simple….when regulations increase so do costs. The intent of regulation is to ensure safety, efficacy, etc which are very good goals to shoot for. The question is that is it worth significantly increasing the cost of a product if there’s no evidence that safety, efficacy, etc is an issue? There needs to be a balance between excessive government regulation and whether there’s a need of protection. I think the first thing that needs studying is why the rush to regulate? Do you have some evidence that it is necessary? I would like to hear that first. Do you really want medical apps to be regulated as drugs are now?? What will happen to the cost of that app? It will rise exponentially which may be good for the app manufacturer but not for the clinician or consumer

  • MobiHealthNews

    Todd, I agree with much of that, especially the need for balance.

    If I understand you correctly, I disagree with the premise here: “The first thing that needs studying is why the rush to regulate?” As I wrote above, the FDA has been regulating mobile medical apps for 17 years. It has asked at least one app developer to remove its app from the Apple AppStore and seek 510(k) clearance. It has cleared more than 76 mobile medical apps since 1996. There is no rush to regulate, it has been here for some time.

    The rush is for clarity. The final guidance document will supposedly help mobile health companies better understand how the FDA determines which apps are medical devices and which aren’t. It’s not a question of “if” the FDA regulates medical apps (it does), but “how”. Some apps are regulated as medical devices are now — not drugs. I think most would agree the sooner regularity clarity comes the better.

    I can’t imagine why uncertainty and confusion on this front would be beneficial to anyone, save those who would prefer the FDA give up this category of medical device as part of its purview. Its inability to produce a final guidance document might be used against it as a competent regulator.

    In almost all cases consumer or patient-facing mobile medical apps with 510(k) clearance today are companion apps for a regulated medical device like a blood glucose meter, connected weight scale, or blood pressure cuff. I can find no case where these companion apps themselves cost additional fees. Their peripheral devices hover in the $100-$200 range.

    Regulated apps that are not sold with a particular (physical/hardware) medical device like those developed by WellDoc or AirStrip Technologies are not direct-to-consumer and either paid for by employers or payers (WellDoc) or by providers (AirStrip).

    Blackburn’s contention that regulating medical apps will drive up the costs of cell phones is ridiculous, as stated. A more credulous version of her arugment might be that mobile phone makers want to advertise that their devices (iPhone, Samsung Galaxy SIV, etc.) are capable of providing various medical services through apps, but making this claim in their marketing puts their smartphones and tablets in danger of being considered medical devices by the FDA.

    I wonder if Apple or Samsung really has an interest in marketing their devices that way. Maybe the Committee will manage to bring Tim Cook to the Hill next week and we can all find out!

  • http://www.yamanoor.com/ Yamanoor Srihari

    Great point Brian. Maybe the first thing we should study is “Why the rush to deregulate?”, but that would mostly be a rhetoric question. :)

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  • http://www.waynecaswell.com Wayne Caswell

    As we decide the proper regulatory balance, we should not to stifle innovation, much of which occurs among start-ups who can’t afford the high price of navigating a complex regulatory environment but have a lot to offer the healthcare community.